Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00029484
Other study ID # R21AT000255-01
Secondary ID
Status Completed
Phase Phase 2
First received January 11, 2002
Last updated August 17, 2006

Study information

Verified date July 2006
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

A randomized control trial testing whether a relaxation response based intervention, Tai Chi Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological adaptation and health function in the older adult.


Description:

Both the incidence and severity of Herpes Zoster (HZ) or "Shingles" increase markedly with increasing age, is a painful condition, due to a decline in Varicella Zoster Virus (VZV) specific immunity. Considerable evidence further shows that psychological stresses salient in the older adult correlate with impairments of cellular immunity.

The investigators have observed that Varicella Zoster Immunity is always decreased in individuals with major depression. Moreover, our preliminary data indicates that the presence of depressive symptoms in older adults is associated with a decline of VZV responder cell frequency (VZV-RCF). Taken together, the untoward effects of age and depressive symptoms on VZV immunity raise the question as to whether an alternative medicine intervention might augment VZV specific immunity in the older adult. We have preliminarily shown that administration of a relaxation-response based intervention, Tai Chi Chih (TCC), results in improvements in health functioning and VZV immunity in older adults as compared to controls. TCC is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations.

This proposed controlled clinical trial aims to: 1) determine whether the practice of TCC for 16 weeks influences Varicella Zoster Virus (VZV) immunity; 2) demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being; and 3) assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in VZV immunity following TCC in older adults.

We hypothesize that this behavioral intervention that prioritizes treatment of excessive physiological arousal can influence one's affective state with effects on cellular immunity. By standardization of training and practice schedules, TCC offers an important advantage over prior relaxation response based therapies. Focus on older adults at increase risk for HZ and assay of VZV specific cellular immunity has implications for understanding the impact of behavioral factors and an alternative medicine intervention on a clinically relevant endpoint and the ability of the immune system to respond to antigens of infectious pathogens.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 80 Years
Eligibility History of Varicella or long-term resident (greater than or equal to 30 years) in the continental United States.

Study Design

Allocation: Randomized


Related Conditions & MeSH terms


Intervention

Behavioral:
Tai chi chih


Locations

Country Name City State
United States University of California, San Diego San Diego California

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. — View Citation

See also
  Status Clinical Trial Phase
Completed NCT00792623 - Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM). Phase 2
Enrolling by invitation NCT05015686 - Safety and Immunogenicity of Live Attenuated Varicella Vaccine in Healthy Population Aged ≥13 Years Old Phase 3
Completed NCT00092430 - Study to Evaluate Frozen Versus Refrigerated MMRV (Combined Measles, Mumps, Rubella, and Varicella) Investigational Vaccine (V221-016) Phase 3
Completed NCT00384397 - A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers Phase 3
Completed NCT00226499 - Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox Phase 3
Completed NCT00402831 - ProQuad® Intramuscular vs Subcutaneous Phase 3
Not yet recruiting NCT06068608 - A Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Profile of TNM005 in Healthy Adult Subjectsy Phase 1
Completed NCT00560755 - Safety Study of ProQuad® rHA in Infants (V221-037) Phase 3
Completed NCT00715234 - Evaluation of Vaccination Reminder/Recall Systems for Adolescent Patients N/A
Terminated NCT00258726 - Immune Responses to Two Dose Varivax +/- MMR-II Phase 1/Phase 2
Completed NCT03239873 - Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03) Phase 3
Completed NCT00751348 - Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 Phase 3
Completed NCT00969436 - Comparison of GSK Measles-mumps-rubella-varicella (MMRV) Vaccine Versus PriorixTM Phase 3
Completed NCT00566527 - Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038) Phase 3
Completed NCT01390857 - Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox) N/A
Completed NCT00127010 - Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases Phase 3
Completed NCT00578175 - Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age Phase 2
Completed NCT00568334 - Study of Two Formulations of GSK Biologicals' Varicella Vaccine Phase 2
Completed NCT03114982 - The Evaluation of Immunogenicity and Safety of NBP608 in Healthy Children 12 Months to 12 Years of Age Phase 2
Completed NCT00483574 - Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers Phase 3